ARTICLE | Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

January 2, 2012 8:00 AM UTC

The Scottish Medicines Consortium again recommended against the use of Allergan's Ozurdex dexamethasone intravitreal implant on the National Health Service (NHS) in Scotland to treat macular edema following either branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO) in adults. The consortium reiterated that Allergan did not present a sufficiently robust clinical and economic analysis of Ozurdex and that the long term effectiveness is uncertain. SMC said Allergan plans to make a second resubmission. The consortium first recommended against the use of Ozurdex in the indication in 2010 for the same reason (see BioCentury, Dec. 20, 2010).

Last year the U.K.'s NICE issued final guidance recommending the use of Ozurdex to treat macular edema following CRVO and following BRVO when laser photocoagulation is not beneficial or suitable (see BioCentury, Aug. 1, 2011). ...